The present invention relates to medical device systems. Specifically, the invention pertains to a remote bi-directional communications with one or more programmers and medical units, or related controls that are associated with implantable medical devices (IMDs). More specifically, the invention relates to a system to aid in the initial implant and subsequent follow-up of IMDs. The invention utilizes a highly integrated system and method of bi-directional telecommunications between a web-based expert data center and a medical device, utilizing various types of network platforms and architecture, to inform patients and clinicians upon connection with the expert data center about recalls or alerts and recommend courses of action relating to the selection of programmable parameters and the course of treatment/follow-up of an IMD.
A technology-based health care system that fully integrates the technical and social aspects of patient care and therapy should be able to flawlessly connect the client with care providers irrespective of separation distance or location of the participants. While clinicians will continue to treat patients in accordance with accepted modern medical practice, developments in communications technology are making it ever more possible to provide a seamless system of remote patient diagnostics, care and medical services in a time and place independent manner.
Prior art methods of clinical services are generally limited to in-hospital operations. For example, if a physician needs to review the performance parameters of an implantable device in a patient, it is likely that the patient has to go to the clinic. Further, if the medical conditions of a patient with an implantable device warrant a continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Such a continued treatment plan poses both economic and social problems. Under the exemplary scenario, as the segment of the population with implanted medical devices increases many more hospitals/clinics including service personnel will be needed to provide in-hospital service for the patients, thus escalating the cost of healthcare. Additionally the patients will be unduly restricted and inconvenienced by the need to either stay in the hospital or make very frequent visits to a clinic.
Yet another condition of the prior art practice requires that a patient visit a clinic center for occasional retrieval of data from the implanted device to assess the operations of the device and gather patient history for both clinical and research purposes. Such data is acquired by having the patient in a hospital/clinic to down load the stored data from the implantable medical device. Depending on the frequency of data collection this procedure may pose serious difficulty and inconvenience for patients who live in rural areas or have limited mobility. Similarly, in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come into the clinic or hospital to have the upgrade installed. Further, in medical practice it is an industry-wide standard to keep an accurate record of past and contemporaneous procedures relating to an IMD uplink with, for example, a programmer. It is required that the report contains the identification of all the medical devices involved in any interactive procedure. Specifically, all peripheral and major devices that are used in down linking to the IMD need to be reported. Currently, such procedures are manually reported and require an operator or a medical person to diligently enter data during each procedure. One of the limitations of the reporting procedure is the fact that it is error prone and requires rechecking of the data to verify accuracy. Further, under present medical device databases, there is no well-defined interactive system that enables patients and clinicians to be aware of recalled or upgradeable units/components for IMDs.
IMDs, programmers and related medical devices are distributed throughout the world. Further, the number of people with implanted medical devices has been increasing over the last few years. Thus, it is important to provide a broadcast system for recalled devices to ensure the safety of these globally distributed medical devices. Specifically, at current global distribution levels a web-enabled alert system of notification is a vital and necessary tool to promote safe therapy and clinical care worldwide.
A further limitation of the prior art relates to the management of multiple medical devices in a single patient. Advances in modern patient therapy and treatment have made it possible to implant a number of devices in a patient. For example, IMDs such as a defibrillator or a pacer, a neural implant, a drug pump, a separate physiologic monitor and various other IMDs may be implanted in a single patient. To successfully manage the operations and assess the performance of each device in a patient with multi-implants requires a continuous update and monitoring of the devices. Further, it may be preferred to have an operable communication between the various implants to provide a coordinated clinical therapy to the patient. Thus, there is a need to monitor the IMDs including the programmer on a regular, if not a continuous, basis to ensure optimal patient care.
Accordingly it is vital to have a programmer unit that would connect to a remote expert data center, a remote web-based data center or a remote data center, all these terms being alternate equivalents as used herein, to provide access to a database of recalled devices. More specifically, it is most desirable to provide globally distributed patients and their doctors information about recalled IMDs and those needing an upgrade consistent with standards set by the manufacturers of the IMDs.
The proliferation of patients with multi-implant medical devices worldwide has made it imperative to provide remote services to the IMDs and timely clinical care to the patient. Frequent use of programmers to communicate with the IMDs and provide various remote services, consistent with co-pending applications titled xe2x80x9cApparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,xe2x80x9d filed on Oct. 26, 1999, Ser. No. 09/426,741; xe2x80x9cTactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,708; xe2x80x9cApparatus and Method for Automated Invoicing of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,208; xe2x80x9cApparatus and Method for Remote Self-Identification of Components in Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,956; xe2x80x9cApparatus and Method to Automate Remote Software Updates of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,960; xe2x80x9cMethod and Apparatus to Secure Data Transfer From Medical Device Systems,xe2x80x9d filed Nov. 2, 1999, Ser. No. 09/431,881; xe2x80x9cImplantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,xe2x80x9d filed Nov. 4, 1999, Ser. No. 09/433,477; xe2x80x9cSystem of Notification of Recalled Components for a Medical Device,xe2x80x9d filed Dec. 29, 1999, Ser. No. 09/474,694; which are all incorporated by reference herein in their entirety, has become an important aspect of patient care. Thus, in light of the referenced disclosures, remote access to a data bank of recalled devices both consisting of Medtronic, Inc. and products made by other manufacturers, is a vital step in providing efficient therapy and clinical care to the patient.
The prior art provides various types of remote sensing and communications with IMDs. Stranberg in U.S. Pat. No. 4,886,064, issued Dec. 12, 1989, for example, discloses one such system. In this disclosure, body activity sensors, such as temperature, motion, respiration and /or blood oxygen sensors, are positioned in a patient""s body outside a pacer capsule. The sensors wirelessly transmit body activity signals, which are processed by circuitry in the heart pacer. The heart pacing functions are influenced by the processed signals. The signal transmission is a two-way network and allows the sensors to receive control signals for altering the sensor characteristics.
One of the many limitations of Stranberg is the fact that although there is corporeal two-way communications between the implantable medical devices, and the functional response of the heart pacer is processed in the pacer after collecting input from the other sensors, the processor is not remotely programmable. Specifically, the system does not lend itself to web-based communications because the processor/programmer is internally located in the patient forming an integral part of the heart pacer.
Yet another prior art reference provides a multi-module medication delivery system as disclosed by Fischell in U.S. Pat. No. 4,494,950 issued Jan. 22, 1985. The disclosure relates to a system consisting a multiplicity of separate modules that collectively perform a useful biomedical purpose. The modules communicate with each other without the use of interconnecting wires. All the modules may be installed intracorporeal or mounted extracorporeal to the patient. In the alternate, some modules may be intracorporeal with others being extracorporeal. Signals are sent from one module to the other by electromagnetic waves. Physiologic sensor measurements sent from a first module cause a second module to perform some function in a closed loop manner. One extracorporeal module can provide electrical power to an intracorporeal module to operate a data transfer unit for transferring data to the external module.
The Fischell disclosure provides modular communication and cooperation between various medication delivery systems. However, the disclosure does not provide an external programmer with remote sensing, remote data management and maintenance of the modules. Further, the system does neither teach nor disclose the notification/recommendation scheme contemplated by the present invention.
An additional example of prior art practice includes a packet-based telemedicine system for communicating information between central monitoring stations and a remote patient monitoring station disclosed in Peifer, WO 99/14882 published Mar. 25, 1999. The disclosure relates to a packet-based telemedicine system for communicating video, voice and medical data between a central monitoring station and a patient that is remotely located with respect to the central monitoring station. The patient monitoring station obtains digital video, voice and medical measurement data from a patient and encapsulates the data in packets and sends the packets over a network to the central monitoring station. Since the information is encapsulated in packets, the information can be sent over multiple types or combination of network architectures, including a community access television (CATV) network, the public switched telephone network (PSTN), the integrated services digital network (ISDN), the Internet, a local area network (LAN), a wide area network (WAN), over a wireless communications network, or over asynchronous transfer mode (ATM) network. A separate transmission code is not required for each different type of transmission media.
One of the advantages of the Pfeifer invention is that it enables data of various forms to be formatted in a single packet irrespective of the origin or medium of transmission. However, the data transfer system lacks the capability to remotely debug or optimize the performance parameters of the medical interface device or the programmer. Further, Pfeifer does not disclose a method or structure by which the devices at the patient monitoring station may be remotely optimized for patient safety or benefit.
In a related art, Thompson discloses a patient tracking system in U.S. Pat. No. 6,083,248 entitled xe2x80x9cWorld-wide Patient Location and Data Telemetry System For Implantable Medical Devices xe2x80x9d, issued on Jul. 4, 2000, which is incorporated by reference herein in its entirety. The ""248 patent provides additional features for patient tracking in a mobile environment worldwide via the GPS system. However, the notification of recalled parts and upgradeable units advanced by the present invention are not within the purview of the Thompson disclosure because there is no teaching of a web-based environment in which a programmer or an interface medical unit (IMU) is used to transfer IMD data for monitoring and to alert the patient and clinician about safety and function improvements to the IMD units.
Yet in another related art, Ferek-Petric discloses a system for communication with a medical device in a co-pending application, Ser. No. 09/348,506, xe2x80x9cSystem for Remote Communication with a Medical Device,xe2x80x9d filed Jul. 7, 1999, which is incorporated by reference herein in its entirety. The disclosure relates to a system that enables remote communications with a medical device, such as a programmer. Particularly, the system enables remote communications to inform device experts about programmer status and problems, the experts will then provide guidance and support remotely to service personnel or operators located at the programmer. The system may include a medical device adapted to be implanted into a patient; a server PC (SPC) communicating with the medical device; the server PC having means for receiving data transmitted across a dispersed data communication pathway, such as the Internet; and a client PC having means for receiving data transmitted across a dispersed communications pathway from the SPC. In certain configurations the SPC may have means for transmitting data across a dispersed data communication pathway (Internet) along a first channel and a second channel; and the client PC may have means for receiving data across a dispersed communication pathway from the SPC along a first channel and a second channel.
One of the significant teachings of Ferek-Petric""s disclosure, in the context of the present invention, includes the implementation of communication systems, associated with IMDs that are compatible with the Internet. Specifically the disclosure advances the art of remote communications between a medical device, such as a programmer, and experts located at a remote location using the Internet. As indicated hereinabove, the communications scheme is structured to primarily alert remote experts to existing or impending problems with the programming device so that prudent action, such as early maintenance or other remedial steps, may be timely exercised. Further, because of the early warning or advance knowledge of the problem, the remote expert would be well informed to provide remote advice or guidance to service personnel or operators at the programmer.
While Ferek-Petric""s invention advances the art in communications systems relating to interacting with a programmer via a communication medium such as the Internet, the system does neither propose nor suggest the notification/recommendation system advanced by the present invention.
In yet another related art Knapp discloses a medical information transponder implant and tracking system in U.S. Pat. No. 5,855,609 issued on Jan. 5, 1999. The disclosure relates to a passive electrical transponder directly transplanted in a patient""s underarm area. Medical devices may also carry transponders to identify them for use with the tracking system of the invention. An identification code is accessed with an electromagnetic hand held reader, which is brought into proximity of the transponder. The medical information may itself be directly encoded into the transponder, or a code used which is then keyed to a corresponding data entry in a data bank or computerized database accessible over telecommunication lines. Accordingly, medical information may be reliably and confidentially recorded and accessed confidentially.
While the Knapp disclosure advances the art of medical information collection for both short term and extended time periods for analysis to generate recall notices and to provide generalized health services, it fails far short of the advances brought about by the present invention. Specifically the present invention provides a statistical survival probability projection based upon the implanted base of IMD units to inform patients and their caregivers to allow optimization of IMD safety and function and improve patient benefits of the therapy provided on a real time basis. More specifically the present invention utilizes a programmer or equivalent interface unit that monitors one or more implanted devices on a chronic basis. The interface unit also transfers the information thus collected to a preferably web enabled expert data center for evaluation, analysis and follow-up. In the process, the implanted devices in the patient are checked against a list of measured parameter limits and projections from a remote database. In the event one or more of the devices measured characteristics are found to be out of specification, the clinician and the patient are notified via a preferably web-enabled communication network.
In yet another related art, in U.S. Pat. No. 5,391,193, Thompson discloses a method and apparatus for estimating the remaining capacity of a lithium-iodine battery through the nomographic analysis of two or more measurements of battery impedance. In a preferred embodiment, a pacemaker or other implantable medical device is provided with circuitry for periodically measuring the internal impedance of its battery. Each measurement of impedance is stored along with an indication of when such measurement was made. Nomographic analysis, based upon the rated capacity of the battery and the expected internal impedance at various stages of depletion, allows for two or more time-stamped impedance measurements to serve as the basis for an extrapolation to estimate the remaining service life of the implantable medical device. Nomographic analysis may be performed by circuitry contained in the implanted device itself; in the alternative, periodic impedance measurements may be communicated to external processing circuitry via a telemetry channel. This system does not use a remote integrated database of statistical survival probability projections to aid in the management of patient safety and IMD longevity actions.
In yet another related art, in U.S. Pat. No.4,979,507, Heinz discloses a system that has as an objective the universal matching of individual patient-pacemaker-implant electrode interface conditions to follow dynamic changes occurring in use, from pacemaker to pacemaker and from patient to patient to control the pacing pulse energy in operation most efficiently to prolong battery life. Information from the implanted stimulation electrode is analyzed to discriminate the energy level of pulses effective and ineffective to stimulate a heartbeat for at least two different stimulation pulse characteristics. This analyzed information is automatically processed in logic circuits to conform to the requirements of particular pacemaker adjustments to develop an optimized energy pacing pulse with adequate safety margin. Programming and logic equipment can be in the pacemaker, but additional energy saving with those calculations takes place when it is external to the pacemaker and bi-directional communication of information takes place with the pacemaker. Periodic automatic programming can take place in implanted pacemaker installations for continuous long term monitoring and control to obtain the optimum battery life and adequate safety standards. This system does not use a remote integrated database of statistical survival probability projections to aid in the management of patient safety and IMD longevity actions.
In yet another related art, in U.S. Pat. No. 5,620,474, Koopman describes a programmable pacing system and method, the system having the capability for providing an indication of recommended replacement time (RRT) as well as a prior warning of six months to RRT. RRT is determined by storing a value in the pacemaker corresponding to battery impedance at RRT, continuously periodically measuring battery impedance, and comparing the measured value with the stored RRT value. Whenever the pacemaker is reprogrammed to different operating conditions which affect RRT, or there is a significant change in load lead resistance, a new value of RRT impedance is calculated based upon a selected formula corresponding to the reprogrammed set of operating conditions, and stored in the pacemaker. At the same time, an aging value of impedance is re-calculated to provide a six-month warning before RRT, and likewise stored in the pacemaker. This system does not use a remote integrated database of statistical survival probability projections to aid in the management of patient safety and IMD longevity actions.
In yet another related art, in U.S. Pat. No. 5,309,919, Snell describes a method and system for monitoring the behavior of an implanted pacemaker counts (records) the number of times that a given internal event or state change of the pacemaker occurs, and also determines the rate at which each event or state change thus counted occurs. The event counts and their associated rate are stored (recorded) in appropriate memory circuits housed within the pacemaker device. At an appropriate time, the stored event count and rate data are downloaded to an external programming device. The external programming device processes the event count and rate data, and displays a distribution of the event count data as a function of its rate of occurrence, as well as other statistical information derived therefrom. The displayed information, and its associated statistical information, allows a baseline recording to be made that establishes the implanted pacemaker""s behavior for a given patient under known conditions. Such baseline recording of event counts in combination with the associated rate of occurrence of such event counts provides significant insight into the past behavior of the pacemaker as implanted in a particular patient. The past behavior of the pacemaker, in turn, may then be used to predict with a high degree of accuracy the future behavior of the pacemaker. This system does not use a remote integrated database of statistical survival probability projections to aid in the management of patient safety and IMD longevity actions.
Accordingly, it would be desirable to provide a system in which one or more implanted devices could uplink to a remote expert data center via an interface medical unit such as a programmer to access a patient and device information database to identify devices or components out of specification and notify the clinician and/or patient as apparent. Yet another desirable advantage would be to provide a system to implement the use of remote expert systems to optimally manage IMDs on a real-time basis. A further desirable advantage would be to provide a communications scheme that is compatible with various communications media, to promote a fast uplink of a programmer to remote expert systems and specialized data resources to chronically monitor IMDs and provide an uninterrupted management of patient therapy and clinical care. Yet another desirable advantage would be to provide a high speed communications scheme to enable the transmission of high fidelity sound, video and data to advance and implement efficient remote data management of a clinical/therapy system via a programmer or an interface medical unit thereby enhancing patient clinical care. Yet a further desirable advantage would be to remotely import a software-based patient and device information for use by local clinicians/operators/technicians using programmers for IMDs distributed throughout the world. Preferably, a remote web-based expert data center would direct, update, command and control a software-based information system worldwide to keep an interconnected scheme in which, among other services, information about improving patient safety and benefit from IMDs are kept for alerting patients or care givers, as needed. As discussed herein below, the present invention provides these and other desirable advantages.
The present invention generally relates to a communications scheme in which a remote web-based expert data center interacts with a patient having one or more implantable medical devices (IMDs) via an associated external medical device, preferably a programmer or an interface medical unit (IMU), located in close proximity to the IMDs. Some of the most significant elements of the invention include the use of various communications media between the remote web-based expert data center and the programmer to remotely exchange clinically significant information and ultimately effect real-time parametric and operational changes as needed.
In the context of the present invention, one of the many aspects of the invention includes a real-time access of a programmer or an IMD to a remote web-based expert data center, via a communication network, which includes the Internet. The operative structure of the invention includes the remote web-based expert data center, in which an expert system is maintained, having a bi-directional real-time data, sound and video communications with the programmer via a broad range of communication link systems. The programmer is in turn in telemetric communications with the IMDs such that the IMDs may uplink to the programmer or the programmer may down link to the IMDs, as needed.
In a further context of the invention, a programmer is remotely monitored, assessed and upgraded as needed by importing expert systems from a remote expert data center via a wireless or equivalent communications system. The operational and functional software of the embedded systems in the programmer may be remotely adjusted, upgraded or changed to ultimately be implemented in the IMDs as needed by down linking from the programmer to the IMDs.
Yet another context of the invention includes a communications scheme that provides a highly integrated and efficient method and structure of clinical information management in which various networks such as Community access Television, Local area Network (LAN), a wide area network (WAN) Integrated Services Digital Network (ISDN), the Public Switched telephone Network (PSTN), the Internet, a wireless network, an asynchronous transfer mode (ATM) network, a laser wave network, satellite, mobile and other similar networks are implemented to transfer voice, data and video between the remote data center and a programmer. In the preferred embodiment, wireless communications systems, a modem and laser wave systems are illustrated as examples only and should be viewed without limiting the invention to these types of communications alone. Further, in the interest of simplicity, the applicants refer to the various communications system, in relevant parts, as a communication system. However, it should be noted that the communication systems, in the context of this invention, are interchangeable and may relate to various schemes of cable, fiber optics, microwave, radio, laser and similar communications or any practical combinations thereof.
Yet one of the other distinguishing features of the invention includes the use a highly flexible and adaptable communications scheme to promote continuous and real-time communications between a remote expert data center and a programmer associated with a plurality of IMDs. The IMDs are structured to share information intracorporeally and may interact with the programmer or IMU, as a unit. Specifically, the IMDs either jointly or severally can be interrogated to implement or extract clinical information as required. In other words, all of the IMDs may be accessed via one IMD or, in the alternate, each one of the IMDs may be accessed individually. The information collected in this manner may be transferred to the programmer by up linking the IMDs as needed.
Further, the present invention provides significant distinctions over the prior art by enabling remote troubleshooting, maintenance and recommendations for patient safety and program enhancements to the IMDs. The communications scheme enables remote debugging, projections and analysis on the programmer. In the event a component defect or end of life projection is nearing, the system is able to check whether a xe2x80x98remote-fixxe2x80x99 and/or programming change is possible. If not, the system broadcasts an alert to clinician thus attending to the problem on a real-time basis. In the execution of this function the communications scheme of the present invention performs, inter alia, a review of usage logs, error logs, power and battery status, database integrity and the projected mean time to failure status of all the significant and relevant components. Further, patient history, performance parameter integrity from the remote expert data center and the IMDs"" diagnostic data are mined from the programmer""s database and analyzed by an analyzer resident in the programmer.
The invention provides significant compatibility and scalability to other web-based applications such as telemedicine and emerging web-based technologies such as tele-immersion. For example, the system may be adapted to webtop applications in which a IMU may be used to uplink the patient to a remote data center for non-critical information exchange between the IMDs and the remote expert data center. In these and other web-based similar applications the data collected, in the manner and substance of the present invention, may be used as a preliminary screening to identify the need for further intervention using the advanced web technologies.
More significantly, the invention provides a system and method to remotely alert the patients/clinician if there are out of specification, or about to be out of specification, devices or components of an implantable medical device. Further, the invention enables the patient/clinician to be aware of IMDs requiring increased follow-up frequency and programming changes. Furthermore, the invention enables the patient/clinician to access web sites tailored to provide pertinent information regarding the patient""s IMDs and general clinical profile.